JP2005027686A - Medical tube and infusion set equipped with the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical tube 12 for preventing a tube of an infusion set from unexpectedly falling out of an infusion container, etc. and preventing a syringe needle 36 from unexpectedly falling out of a human body, and an infusion set using the same. <P>SOLUTION: The 50% tensile stress M<SB>50</SB>of the medical tube 12 is 1.5-3.5 MPa, and the ratio of M<SB>50</SB>to the 100% tensile stress M<SB>100</SB>is 1:1-1:1.2. Since M<SB>50</SB>of the medical tube 12 is small, the tube can be stretched with relatively small force, and since the ratio of M<SB>100</SB>to M<SB>50</SB>is also small, the stretch can be further increased with a force having the same level as the start of the stretch. Even if the medical tube 12 is unexpectedly pulled, the impact can be absorbed as the medical tube itself is stretched, and disconnection between tubes 12 and 14 and the syringe needle 34, etc. and falling of the syringe needle 34 out of an arm of a patient can be prevented. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

[0001]
【Technical field】
The present invention relates to a medical tube and an infusion set including the medical tube. More specifically, the medical tube for preventing the tube of the infusion set from unexpectedly falling out of an infusion container or the like, and the injection needle from accidentally falling out of the human body. Concerning tubes and infusion sets.
[0002]
[Background]
When the infusion set is pulled unexpectedly when the patient changes posture or moves his arm greatly during infusion, (a) the puncture needle attached to the tip of the tube is the mouth of the infusion container (B) The tube is disconnected from the injection needle, three-way stopcock adapter, etc., (c) The injection needle attached to the other end of the tube is dropped from the patient's arm, etc. There is a risk of disconnection of the connection with the catheter. In this case, there is a problem that the drip solution leaks, a risk of infection from the needle or tube that has fallen out, or a serious accident such as death of the patient's blood leaking.
[0003]
Therefore, Patent Document 1 proposes an infusion set in which a screwing mechanism is introduced to the connection portion so that the tube does not fall out of the infusion container. However, this infusion set only prevents the dropout between the infusion container and the tube, and cannot completely prevent the problems (b) and (c).
[0004]
[Patent Document 1]
Japanese Patent Laid-Open No. 10-248938 (Claim 1, FIG. 1)
[0005]
[Problems to be solved by the invention]
Accordingly, an object of the present invention is to provide a medical tube for preventing a tube of an infusion set from unexpectedly falling out of an infusion container or the like, or an injection needle from accidentally falling out of a human body, and an infusion using the medical tube. Is to provide a set.
[0006]
[Means for Solving the Problems]
The medical tube of the present invention for achieving the above object has a 50% tensile stress of 1.5 to 3.5 MPa, and a ratio of 50% tensile stress to 100% tensile stress (M ₅₀ : M ₁₀₀ ). Is 1: 1 to 1: 1.2. A more preferred embodiment of such a medical tube has a 50% tensile stress of 2.0 to 3.0 MPa and a ratio of 50% tensile stress to 100% tensile stress (M ₅₀ : M ₁₀₀ ) of 1: 1. 05 to 1: 1.15.
[0007]
Currently, most of the tube bodies of medical tubes used in infusion sets are made of vinyl chloride resin or polybutadiene resin. The 50% tensile stress of the tube body made of these materials exceeds 3.5 MPa, and in the case of a vinyl chloride resin, it is 5 MPa or more. In addition, the ratio of 50% tensile stress to 100% tensile stress both exceeds 1.2, and in particular, the vinyl chloride resin shows a large value of about 1.5.
[0008]
On the other hand, since the 50% tensile stress of the medical tube of the present invention is smaller than the 50% tensile stress of a tube used in a conventional infusion set or the like, the tube is stretched with a relatively small force. Can be made. Moreover, since the ratio of 50% tensile stress to 100% tensile stress is small, that is, the 100% tensile stress itself is small, the elongation is further increased with the same level of force as when the tube begins to grow. be able to.
[0009]
Therefore, for example, when the infusion is performed with the infusion set using the medical tube of the present invention, even if the tube is unexpectedly pulled by changing the posture or moving the arm greatly, the above medical The impact at that time can be absorbed by the extension of the tube. As a result, (a) the puncture needle attached to the tip of the tube falls out of the mouth plug of the infusion container, (b) the tube is disconnected from the injection needle, the three-way stopcock adapter, etc. c) It is possible to prevent the problem that the injection needle attached to the other end of the tube falls off from the patient's arm or the like, or the connection portion with the central venous catheter is disconnected. Thus, the medical tube of this invention is suitable for uses, such as a tube for conveying the chemical | medical solution for drip, for example.
[0010]
The medical tube of the present invention is preferably made of a resin composition containing a mixture of a polyolefin and a thermoplastic elastomer having compatibility with the polyolefin. The mixture contained in the resin composition is preferably composed of 5 to 95% by weight of polyolefin and 95 to 5% by weight of thermoplastic elastomer having compatibility with the polyolefin. By using the resin composition as a forming material of the tube body, particularly by setting the mixing ratio of the polyolefin and the thermoplastic elastomer in the mixture contained in the resin composition within the above range, the tensile properties of the tube body Can be set so as to satisfy the above conditions, and a tube suitable for use in the medical field can be obtained.
[0011]
In order to achieve the above object, an infusion set of the present invention comprises the medical tube of the present invention. As described above, the medical tube of the present invention is characterized in that the tensile stress required to cause the tube main body to stretch and further increase the elongation is small. Therefore, by using the medical tube of the present invention as a tube of the infusion set, an infusion set can be obtained even if the patient changes his posture or moves his arm greatly during infusion. The impact applied to the infusion set due to the extension deformation of the tube can be absorbed. Therefore, it is possible to prevent the problems as shown in the above (a) to (c) from occurring.
[0012]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
One embodiment of an infusion set using the medical tube of the present invention is shown in FIG. The infusion set 10 of the present invention has the medical tube 12 of the present invention at least in a part thereof. In the embodiment shown in FIG. 1, the puncture needle is sequentially formed from the side to be pierced through the mouth plug of the infusion container. 16, a drip tube 18, a tube 14, a V clamp 22, a three-way cock 24, a side spout 26, a medical tube 12, and an injection needle 34. In the infusion set 10 shown in FIG. 1, the medical tube 12 of the present invention is arranged following the injection needle 34, but the arrangement position of the medical tube 12 is not limited to this, and for example, a three-way cock 24 It may be arranged in the vicinity of puncture needle 16 or the like.
[0013]
In the infusion set 10 shown in FIG. 1, when the infusion set 10 is unexpectedly pulled due to a patient changing posture or moving his arm greatly during infusion, (a) a puncture attached to the tip of the tube 14 In addition to the needle 16 falling off from the mouth plug of the infusion container, (b) the connection at the connection portion 20 between the tube 14 and the drip tube 18 and the connection portions 28 and 30 between the tube 14 and the three-way cock 24 are disconnected. Or (c) the injection needle 34 attached to the distal end of the tube 12 may fall off the patient's arm or the like. However, since the infusion set 10 shown in FIG. 1 uses the medical tube 12 as a part of the infusion set 10, even if a situation such as the infusion set 10 being pulled unexpectedly occurs, the medical tube 12 exhibits an expansion deformation. In this case, since the impact caused by the unexpected pull is absorbed, the problems as shown in the above (a) to (c) do not occur. In addition, the connection part 32 of the medical tube 12 and the other tube 14 is normally firmly connected by well-known adhesion methods, such as the ultrasonic sealing method.
[0014]
<Tensile stress of medical tube>
The tensile stress of the medical tube according to the present invention is measured according to JIS K 7311 using a test piece obtained by cutting the tube body.
(50% tensile stress)
The 50% tensile stress (tensile stress M ₅₀ at 50% elongation) of the medical tube according to the present invention is set in the range of 1.5 to 3.5 MPa.
[0015]
The lower limit of the 50% tensile stress M ₅₀ becomes liable tube is extremely elongation falls below the above value, it can not maintain the shape of the tube itself. In the above allowable range for M _50, the lower limit is preferably particularly 2.0 MPa.
On the other hand, if the upper limit of the 50% tensile stress M ₅₀ exceeds the above value, the tube will not easily stretch. Therefore, when the tube is unexpectedly pulled, the tube is stretched to absorb the impact at that time. The effect of the period cannot be obtained. In the above allowable range for M ₅₀ , the upper limit is preferably 3.0 MPa, more preferably 2.5 MPa.
[0016]
(Ratio of 50% tensile stress to 100% tensile stress)
The ratio (M ₅₀ : M ₁₀₀ ) of 50% tensile stress M ₅₀ and 100% tensile stress (tensile stress M ₁₀₀ at 100% elongation) of the medical tube according to the present invention is 1: 1 to 1: 1. A range of 2 is set.
The lower limit of the ratio of _{M 100} is the range at the time of the M ₅₀ and 1 (1) those below _{(i.e., those M 100} is below _{M 50)} for are difficult to normally produce this . The lower limit of the ratio of _{M 100} at the time of the M ₅₀ and 1, particularly preferably 1.05.
[0017]
When the ratio of M ₁₀₀ at the time of the M ₅₀ and 1 exceeds the upper limit of the above range (1.2), even though the force required to cause elongation in a tube (M ₅₀₎ is small, a further elongation Since the force (M ₁₀₀ ) required to cause the increase is increased, the intended effects of the present invention cannot be fully exhibited. The upper limit of the ratio of _{M 100} at the time of the M ₅₀ and 1, particularly preferably 1.15.
<Formation material for medical tubes>
Resin and / or thermoplastic elastomer is used for the material forming the medical tube according to the present invention. Any resin or thermoplastic elastomer may be used as long as its tensile stress satisfies the above-mentioned conditions and medical safety is established, and other matters are not particularly limited. However, among various resin / thermoplastic elastomer materials, it is preferable to use a material that has a small amount of adsorbed drug and hardly generates an eluate such as a plasticizer. Specifically, examples of the resin / thermoplastic elastomer include a mixture of polyolefin and a thermoplastic elastomer having compatibility therewith.
[0018]
Examples of the polyolefin include polyethylene and polypropylene that are widely used for medical purposes. The density, melt flow rate (MFR), molecular weight distribution, stereoregularity, etc. of these polyolefins are not particularly limited, and can be appropriately selected from a wide range according to the tensile stress required for the tube.
Examples of the thermoplastic elastomer having compatibility with the polyolefin include polyolefin-based elastomers such as ethylene / α-olefin copolymer elastomers and proprene / α-olefin copolymer elastomers; styrene / ethylene / styrene / ethylene block copolymers Examples thereof include elastomers (SEBS) and styrene elastomers such as styrene / butadiene / styrene block copolymer elastomers (SBS).
[0019]
The mixing ratio of the polyolefin and the thermoplastic elastomer is preferably 5 to 95% by weight of polyolefin and 95 to 5% by weight of thermoplastic elastomer. By setting the mixing ratio of both in such a range, the tensile stress of the tube can be set in the aforementioned range.
The lower limit of the polyolefin content is preferably 10% by weight within the above range (that is, the upper limit of the thermoplastic elastomer content is 90% by weight), and the upper limit of the polyolefin content is 90% within the above range. It is preferably wt% (that is, the lower limit of the thermoplastic elastomer content is 10 wt%).
[0020]
In the present invention, a mixed resin of a polyolefin and an ethylene / vinyl acetate copolymer can be used as a material for forming a medical tube in place of a mixture of a polyolefin and a thermoplastic elastomer compatible with the polyolefin. .
Moreover, liquid paraffin etc. can be mix | blended with the formation material of a medical tube as needed, and a well-known plasticizer can be mix | blended.
<Layer structure of medical tube>
The medical tube according to the present invention may be a tube having a single layer structure made of the above-described forming material, or may have a multilayer structure with the above-described polyolefin or thermoplastic elastomer. In either case, the medical tube may satisfy the above-described tensile stress condition as a whole.
[0021]
What is necessary is just to set the diameter and wall thickness of the medical tube which concerns on this invention to the same grade as the tube used for a normal infusion set. For example, it is appropriate to set the inner diameter to 2 to 7 mm and the wall thickness to about 0.5 to 1.5 mm.
<Method for producing medical tube>
The tube main body in the medical tube of this invention can be manufactured by the method similar to shape | molding a normal resin product. Specifically, an extrusion molding method can be employed for manufacturing a medical tube.
[0022]
<Infusion set>
When applying the medical tube of this invention to an infusion set, it is preferable to use the said medical tube for a part of tube which comprises an infusion set. If all the tubes of the infusion set are composed of the medical tube of the present invention, the degree of elongation of the tube may be too large. Specifically, the length of the medical tube of the present invention is preferably set to about 5 to 50 cm.
[0023]
The position where the tube body is employed is not particularly limited. For example, in an infusion set using an infusion pump, it is preferable to use the tube body as a tube between the pump and the patient.
The connection between the above-described tube and another tube can be performed by a known bonding method such as an ultrasonic sealing method, although it varies depending on the type of resin material forming the tube.
[0024]
【Example】
(Example 1)
(1) Manufacture of tube By using a resin composition consisting of 10% by weight of polypropylene and 90% by weight of propylene / 1-butene copolymer elastomer, a tube having an inner diameter of 2.1 mm and a wall thickness of 0.7 mm is extruded. Manufactured. “Random PP” (density 0.90 g / cm ³ , MFR 10 g / 10 min (230 ° C.)) manufactured by Mitsui Chemicals, Inc. is used for polypropylene, and “Toughmer” is used for propylene / 1-butene copolymer elastomer. A (R) "was used respectively.
[0025]
Stress _{M 50} tensile 50% of the resulting medical tubing thus a 2.3 MPa, 100% tensile stress _{M 100} was 2.53MPa. Therefore, the ratio M ₅₀ : M ₁₀₀ of both was 1: 1.1).
(2) Production of Infusion Set Using the medical tube produced in (1) above and a polybutadiene tube (thickness 0.7 mm, inner diameter 2.5 mm), the infusion set 10 shown in FIG. 1 was produced. .
[0026]
Of the tubes (total length: about 150 cm) of the infusion set 10, the length of the medical tube 12 obtained in the above (1) was 20 cm, and this medical tube 12 was disposed adjacent to the injection needle 34.
(3) Performance evaluation test About the infusion set 10 obtained in the above (2), the puncture needle 16 attached to one end is pierced through the mouth plug of the drug solution container, and the injection needle attached to the other end With the 34 fixed, the chemical container was pulled with a force of about 10 N. As a result, stretching deformation was observed in the medical tube 12 portion. Further, the puncture needle 16 and the injection needle 34 fall off from the mouth plug and the connection part 36 of the drug solution container, the connection part 20 between the tube 14 and the drip tube 18, and the connection parts 28 and 30 between the tube 14 and the three-way stopcock 24. There was no problem such as disconnection.
[0027]
The present invention is not limited to the above description, and various design changes can be made within the scope of the matters described in the claims.
[Brief description of the drawings]
FIG. 1 is an explanatory view showing an embodiment of an infusion set including a medical tube of the present invention.
2 is an explanatory view showing a state when a predetermined tensile stress is applied to the infusion set shown in FIG. 1. FIG.
[Explanation of symbols]
10 Infusion set 12 Medical tube

Claims (5)

A medical tube having a 50% tensile stress of 1.5 to 3.5 MPa and a ratio of 50% tensile stress to 100% tensile stress of 1: 1 to 1: 1.2. A medical tube having a 50% tensile stress of 2.0 to 3.0 MPa and a ratio of 50% tensile stress to 100% tensile stress of 1: 1.05 to 1: 1.15. The medical tube according to claim 1 or 2, comprising a resin composition comprising a mixture of a polyolefin and a thermoplastic elastomer having compatibility with the polyolefin. The medical tube according to claim 3, wherein the mixture comprises 5 to 95% by weight of a polyolefin and 95 to 5% by weight of a thermoplastic elastomer having compatibility with the polyolefin. An infusion set comprising the medical tube according to claim 1.

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